May 5, 2011

Naltrexone: can a pill cure alcoholism?

January 12, 2009 Naltrexone: can a pill cure alcoholism? Naltrexone is cheap, effective and requires no costly rehab. So why do so few doctors endorse it?
Penny Wark

Mrs M, as she asks me to call her, isn't sure exactly when she last drank herself into a comatose state, but she knows it was about five years ago. At that time she got through a bottle or two each day - and not just wine, she explains. “It was the only way I knew to resolve a problem.”

When I spoke to her last week she had not had a drink for four days, though she expected to have a couple of glasses of wine with a meal on Friday night and the same on Saturday. “Oh yes, I still enjoy good wine. I savour wine. But there's no craving.”

For anyone who has encountered alcoholism, whether personally or through friends and family, Mrs M's win-win trouncing of her condition may sound too good to be true. We all know that the only way alcoholics can lead normal lives - as Mrs M does now - is to abstain, and that abstention must be absolute because alcoholics have a distressing habit of resuming their worst excesses after just one drink. Once an alcoholic, always an alcoholic and all that. So how has she done it?

The answer lies in the use of a drug called naltrexone, which Mrs M takes before she drinks. Naltrexone interrupts the pathways in the brain that enable alcohol to release pleasure-giving endorphins. As Matt, another naltrexone user and recovering heavy drinker, puts it: “With naltrexone, it's weird. You drink and you feel the effect of the alcohol but it doesn't have the magic.”

If, each time you engage in a behaviour that releases endorphins, you strengthen that behaviour, it follows that if you engage in the behaviour and don't get the endorphin release, you weaken the urge to use it. Thus, unburdened by a craving for alcohol, a former heavy drinker can use alcohol with control.

That is the theory and this treatment for alcoholism is called the Sinclair Method, after David Sinclair, the scientist who discovered it and who claims a 78 per cent success rate over three to four months. The measure of success is controlled drinking within normal safety limits, or abstinence.

In Finland, where Sinclair works at the National Public Health Institute, his method has become part of the mainstream treatment for alcoholism, used by 100,000 people since 1995, he estimates. In the US it is used by 2 per cent of doctors who treat alcoholism. In the UK, however, naltrexone is licensed for the treatment of heroin addiction but not alcoholism (though it is available on private prescription) and Mrs M, who lives in Scotland, is fortunate to have an enlightened doctor who has sought permission to use it to treat alcohol problems for about 50 carefully selected patients over the past ten years.

Two months ago a book championing the Sinclair Method was published in the US. Called The Cure for Alcoholism, it has sold a few thousand copies but received no media coverage. In it the author, Roy Eskapa, a psychologist who has worked with Sinclair since the 1990s, hails him as a genius who deserves a Nobel prize for finding a cure for the world's biggest killing disease. According to the World Health Organisation, alcohol addiction kills 1.8 million people a year, and in the UK the British Medical Association estimates that one adult in 25 is alcohol-dependent. Sinclair's work could change the way in which society perceives addiction, making it a treatable condition rather than incurable, Eskapa maintains.

His claims are big - preposterous, some would say. But perhaps the most remarkable aspect of this story, which began some 40 years ago, is that while Sinclair can name 76 clinical trials that prove the efficacy and safety of his method, most alcohol addiction professionals don't know about it, or reject it. “I cannot help remarking that anyone who claims to have found a ‘cure for alcoholism' cannot be taken seriously,” says one of the UK Government's eminent advisers on alcoholism.

To understand why the Sinclair Method is often ignored, we need first to look at how Sinclair made his discovery. In 1964, as an undergraduate at the University of Cincinnati, he was involved in research on alcohol and rats. Given rats that had been denied alcohol for two weeks, he decided to test a theory and gave them a choice of an alcohol solution or water. Even though it was daytime, a rat woke up and “started drinking the alcohol solution almost out of my hands”, says Sinclair. The other rats joined in. After more studies, Sinclair began to see that the more the rats were deprived of alcohol, the more they craved it.

“Nobody had seen motivation for alcohol in a rat before,” he says. “This changed the understanding of what causes alcoholic drinking. At that time almost everybody in the field accepted that there wasn't enough pleasure from drinking alcohol to make an alcoholic drink. The pleasure didn't match the unpleasantness, so they theorised that the craving was caused by withdrawal symptoms, by physiological dependence, and all alcoholics were drinking to avoid withdrawal. So the main treatment was to get rid of the physiological dependence - you sent them to rehab with the idea that they would come out and have no reason to drink. If dependence was the cause, it should have been a cure, but it isn't.

“So we starting rethinking what causes alcoholism. It is learnt. A person isn't born an alcoholic but every time they drink there is a release of endorphins. For genetic reasons some people have very powerful receptors for endorphins, get a lot of reinforcement from the alcohol and have a high risk of developing alcoholism. The neural structure that is causing this behaviour, and the craving, gets stronger each time they drink, and with some people it becomes so strong that they can't control it. The only solution is somehow to weaken the behaviour that is so powerful.”

Sinclair moved to Finland in 1972 and, after many more studies, he decided that the best drug to extinguish alcoholic craving was naltrexone. It is not addictive, it has been proved to be safe in 50mg doses, it does not require detoxification because it reduces craving slowly, and it is cheap - about £170 for three months' supply.

Balancing the numerous trials that prove that it leads to controlled drinking, loss of craving and sometimes voluntary abstinence for alcoholics and heavy drinkers, there are also 36 trials that indicate that naltrexone does not work if you are abstinent when you start using it. The Sinclair Method is specific: naltrexone plus alcohol equals cure. For it to work, you have to continue to drink. You take naltrexone only on the days you drink and, as your craving for alcohol reduces, you will drink less. If eventually you choose not to drink, you will not take naltrexone.

The need to continue to drink initially is the main reason why the Sinclair Method has been rejected by so many alcohol addiction professionals. Most are wedded to the idea promulgated by Alcoholics Anonymous's 12-step programme that treatment must involve abstinence. Naltrexone was endorsed for use in alcoholism by the World Health Organisation in 1994 and by the US Food and Drug Administration in 1995. In 2006 the American Medical Association recommended it for treating alcoholism in generalised medical settings. Yet many doctors appear to be uncomfortable advising patients that they must take a drug and also drink - so, when they prescribe it, they insist on abstinence.

Two of the US users of naltrexone to whom I spoke had been unable to get it on prescription. One lied to a psychiatrist, saying that he was abstinent and wanted to use the drug to help with cravings (it doesn't work when used in this way), the other bought it without prescription on the internet. Both reported a steady decline in their craving for alcohol after two months.

Sinclair and Eskapa also believe that the commercial interests of the drug industry - naltrexone is a generic drug - and the £4 billion-a-year rehabilitation business make the Sinclair Method an unpoular choice: there is little money to be made from giving an outpatient a prescription for naltrexone. As one doctor said to Sinclair when he gave a presentation about it at a detox clinic in Virginia: “Yes, but how do we make a living?”

Could the Sinclair Method kill off the alcohol rehab industry? I ask Sinclair. “It could,” he replies, “though some people will still need detox if their liver is too shot to take naltrexone.” Calls to the Priory Group in the UK elicited only the response that doctors there don't know enough about the Sinclair Method to comment. Which raises the question: why not? At Winthrop Hall in Kent, David Bremner, the medical director, said that he uses a combination of cognitive behavioural therapy, family therapy and the 12-step programme “because we use what works” and because the outcomes for controlled drinking compare poorly with abstinence, which he recommends.

Sinclair would dispute that: one clinical trial shows a 50 per cent success rate for the Sinclair Method after three years; three-year figures for the 12-step programme are more commonly about 5 per cent. “We would certainly use the Sinclair Method if it was going to enhance a client's chance of recovery,” says Bremner. “Where Sinclair is to be commended is that he's not trying to make money out of it.”

In Edinburgh Dr Jonathan Chick, consultant psychiatrist at the NHS Lothian Alcohol Problems Service, continues to see Mrs M every six weeks. He prefers to use naltrexone in conjunction with counselling, in spite of clinical trials that suggest that this is unecessary.

“Naltrexone does indeed reduce some of the brain-stimulation effects of alcohol,” says Chick. “I don't think it's right to claim that this is a universal solution for all people who have problems with excessive drinking but it does help some. We prescribe it to people who continue to drink in the hope that it will reduce the frequency of the sessions where they drink to excess and put themselves at risk. If they take naltrexone before they drink, they can have some satisfaction from the taste and some mental effect from the alcohol but report that they don't want to carry on and ‘lose control' of the amount they drink. Unfortunately, quite a lot of our patients don't take it as prescribed.”

Chick agrees that naltrexone may not serve the commercial interests of the pharmaceutical industry. “The other reason the Sinclair Method hasn't been taken up is a very correct reservation about sanctioning continued drinking by people with severe alcohol problems. For many, complete abstinence is by far the best method and needs to be applied quickly. Those who espouse that can do very well. If I was asked by a patient who had been abstinent for a year if I would give him naltrexone so he could resume drinking, I would advise against it.”

Mrs M, who is 55, doesn't see naltrexone as a cure-all either, and can't imagine taking it without the support of her family and Dr Chick. “It's helped to stop me picking arguments, I've got my personality back and my marriage wouldn't have survived without it,” she says. “You can use it as you wish, as long as someone explains everything fully. It's not a magic wand but I can't understand why it's not widely available. It needs to be widely discussed.”